Job Search Agent
Sign up for our Job Search Agent and get E-Mail
of Jobs that match your search requirements!

What is a Clinical Research?

Clinical research
is a branch of medical science that determines the safety and
effectiveness of medications, devices, diagnositc products and
treatment regimens intended for human use. These may be
used for prevention, treatment, diagnosis or for relieving
symptoms of a disease.

In the
United States, when a test article is unapproved or
not yet cleared by the FDA, or when an approved or
cleared test article is used in a way that may
significantly increases the risks (or decreases the
acceptability of the risks), the data obtained from
the pre-clinical studies or other supporting
evidence, case studies of off label use, etc. are
submitted in support of an Investigational New Drug
(IND) application to the Food and Drug
Administration (FDA) for review prior to conducting
studies that involve even one human and a test
article if the results are intended to be submitted
to or held for inspection by the FDA at any time in
the future (in the case of an already approved test
article, if intended to submit or hold for
inspection by the FDA in support of a change in
labeling or advertising). Where devices are
concerned the submission to the FDA would be for an
Investigational Device Exemption (IDE) application
if the device is a significant risk device or is not
in some way exempt from prior submission to the FDA.
In addition clinical research may require
Institutional Review Board (IRB) or Research Ethics
Board (REB) and possibly Other institutional
Committee reviews, Privacy Board, Conflict of
Interest Committee, Radiation Safety Committee,
Radioactive Drug Research Committee, etc. approval
whether or not the research requires prior
submission to the FDA. Clinical research review
criteria will depend on which Federal regulations
the research is subject to (e.g., [(Department of
Health and Human Services (DHHS) if Federally
funded, FDA as already discussed) and will depend on
which regulations the institutions subscribe to, in
addition to any more stringent criteria added by the
institution possibly in response to state or local
laws/policies or accreditation entity
recommendations. This additional layer of review (IRB/REB
in particular) is critical to the protection of
human subjects especially when you consider that
often research subject to the FDA regulation for
prior submission is allowed to proceed, by those
same FDA regulations, 30 days after submission to
the FDA unless specifically notified by the FDA not
to initiate the study. Wikipedia.org